Received Mar 10, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HEP | HEP B (HEPLISAV-B) | DYNAVAX TECHNOLOGIES CORPORATION | 1 | — | — |
Fainting; Flush; Elevated Inflammation; 12 Year Old Female Received HEPLISAV-B; Nausea; Stomach Pain; Dizzy Spells; Fatigue; Initial report received on 18-Feb-2026. A reporter in the US reported that a 12-year-old female received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization and developed flush, nausea, stomach pain, dizzy spells, fainting, fatigue, and elevated inflammation. No medical history or concomitant medications were reported. On 13-Sep-2022, the patient received dose 1 of a hepatitis B vaccine [HEPLISAV-B (lot number, expiration date, NDC number, route, and site not available)]. The patient was 12-years-old when she received HEPLISAV-B. Concomitant vaccines administered included a dose of a meningococcal vaccine [(MENQUADFI (lot number not available)] and a dose of a measles, mumps, and rubella vaccine [MMR (lot number not available)]. On 13-Sep-2022, within 30 minutes of receiving HEPLISAV-B and two other vaccines, the patient experienced flush, nausea, and stomach pain. The patient continued to decline in health, experiencing dizzy spells, fainting, fatigue, and elevated inflammation. The reporter declined to provide further information. Company Comment: The company assessed the events as non-serious. The events are likely associated with an anxiety-related vaccination reaction.; Sender's Comments: The company assessed the events as non-serious. The events are likely associated with an anxiety-related vaccination reaction.
Menquadfi; Mmr